Food additives data book - wordpres

In 1985, National Academic of Science (NAS) and National Research Council (NRC) decided that
cyclamates act as carcinogen promoters or co-carcinogens in the presence of substances like saccharin.
LD50 of sodium cyclamate is 15.25–17.0 g/kg.
LEGISLATION:
USA:
Approved by USFDA in 1949. GRAS status by USFDA in 1957. Banned in US in 1969 for general-purpose foods based on studies linking bladder
tumours in rats with repeated use of cyclamate :saccharin blend in rats. Banned for all foods in August 1970 by US FDA
CFR 21 PART 189: 189.135 – Cyclamate and its derivatives.
[42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 54 FR 24899, June 12, 1989]
(a) Calcium, sodium, magnesium and potassium salts of cyclohexane sulfamic acid: (C6H12NO3S)2Ca, (C6H12NO3S)Na, (C6H12NO3S)2Mg, and
(C6H12NO3S)K. Cyclamates are synthetic chemicals having a sweet taste 30 to 40 times that of sucrose, are not found in natural products at levels
detectable by the official methodology, and have been used as artificial sweeteners.
(b) Food containing any added or detectable level of cyclamate is deemed to be adulterated in violation of the act based upon an order published in the
FEDERAL REGISTER of October 21, 1969 (34 FR 17063).
(c) The analytical methods used for detecting cyclamate in food are in sections 20.162–20.172 of the Official Methods of Analysis of the Association of
Official Analytical Chemists, 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington VA 22201–3301, or may be examined at the Office of the Federal Register, 800 North Capitol Street,
NW., suite 700, Washington, DC 20408.
ADI level as of 1990 for use in soft drinks: Not permitted
UK and EUROPE:
Still permitted in some applications in countries such as Spain, Germany and Switzerland.
JECFA approved cyclamates with an ADI of 11 mg/kg body weight in 1982. Accepted in UK in 1964. EEC Directive on Additives includes cyclamates on
the positive list.
Regulatory Status: ADI level as of 1990 for use in soft drinks;
– JECFA – 0 to 11mg/kg body weight
– Belgium 400 mg/l (pending approval for change from Not Permitted)
– Denmark 250 mg/l
–Finland 100 to 400 mg/l depending upon type of soft drink
–France Not permitted
– East Germany 450 to 600 mg/l depending upon type of soft drink
Cyclamate 927